Pharmaceutical Technology, Aug 2, 2007 - Pharmaceutical Technology

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Pharmaceutical Technology, Aug 2, 2007
Articles
Innovation in Biological Indicator Evaluator Resistometer Vessel Technology
By Kurt McCauley , John R. Gillis , James P. Agalloco
The authors examine advances in the design and the application of biological indicator evaluator resistometer vessels used to measure the resistance of bacterial spores in monitoring sterilization processes.
Favorable Outlook for Generic APIs
By Patricia Van Arnum
A spate of drugs are scheduled to come off patent, offering vast potential and competition.
The Application of Robotics to Aseptic Environmental Surface Monitoring
By Mayumi Maruyama , Tomoo Matsuoka , Motonari Deguchi , James E. Akers
This article presents a study of an aseptic environmental monitoring system for surface contamination at critical areas using a robot.
Preparing for FDA Inspections in a Changing Regulatory Environment
By Angie Drakulich , Maribel Rios
Industry and regulatory experts provide advice on inspection preparation and best practices.
Washington Report
Ensuring Quality for Dietary Supplements
By Jill Wechsler
FDA's long-awaited GMPs for supplements appear as food and drug safety concerns override lingering opposition.
Packaging Forum
Protecting the Cold Chain
By Hallie Forcinio
Makers of temperature-sensitive products constantly seek to ensure proper conditions during shipping and storage.
Inside USP
Inside USP: Revising USP General Notices
By Roger L. Williams , Todd L. Cecil , Ruth K. Miller , Stefan Schuber, PhD
USP is revising key documents to make them easier to use.
Outsourcing
Dose Manufacturing Capacity Growing in Low-Cost Countries
By Jim Miller
FDA approvals renew the threat of competition from India and China.
Agent-In-Place
Supplier Woes
By Control, a senior compliance officer
Production sometimes follows the law of supply and reprimand.
Viewpoint
Big Changes for USP
By Neil Schwarzwalder
Feedback is urged on USP's proposed revisions to the General Notices.
From The Editor
A Moral Decision, A Vital Consequence
By Michelle Hoffman
By vetoing stem cell research funding, the President is vetoing potentially life-saving treatments.
This Time Around
Paving Way for Pediatric Drug Safety
By Angie Drakulich
Did you know that only one-third of prescribed pediatric drugs have been studied or labeled for pediatric use? The Best Pharmaceuticals for Children Act (BPCA) was enacted in 2002 to improve this statistic by providing companies with six months of additional marketing exclusivity if they conduct pediatric trials. The Government Accountability Office recently issued a report that examined data from studies conducted between 2002 and 2005 for drugs specified by the US Food and Drug Administration under BPCA.
Book Review
All Routes Lead to Enhancement
By Gurvinder Singh Rekhi
The book comprehensively reviews the basics of drug absorption and methods for delivery enhancement through various routes of administration.
In the Spotlight
In the Spotlight
The "Solo-VPE" device from C Technologies (Bridgewater, NJ) improves UV–vis measurements by matching the length of the light path to the sample. The unit's software lets users establish thresholds, and the machine adjusts the pathlength and wavelength accordingly. Mark Salerno, director of manufacturing at C Technologies, says the device "... works for you until it finds the measurement range you want it to be in." He adds that the unit expands the operational range of UV–vis instruments. It facilitates measurements from roughly 50 μm to more than 10 mm. Measurements can be adjusted in 10-μm increments.
Pharma Capsules
Pharma Capsules
Cook, ABB, Tyco, and Mettler-Toledo Gain New Managment
In the Field
In The Field
Washington, DC (June 25)—More than five million US adults import prescription drugs from other countries, two million of them without an official prescription, according to a survey conducted by the Pharmaceutical Research and Manufacturers of America (PhRMA). Concerned about the number of counterfeit drugs entering the US, PhRMA launched the survey to determine who was importing prescription drugs and why.

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FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
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Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
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Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
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